Over-the-Counter Hearing Aids: Past, Present, Future

Updated: May 08, 2023
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What Are Over-the-Counter Hearing Aids?

The push for over-the-counter (OTC) hearing aids came in 2017 when Congress passed a law called the OTC Hearing Aid Act. That law requires the Food and Drug Administration (FDA) to lessen restrictions on producing air conduction hearing aids to make them more affordable for the average American.

Air conduction hearing aids are used to treat age-related hearing loss.

The FDA estimates that only one-fifth of the nearly 30 million Americans who need hearing aids actually obtain them, with high costs being a major barrier to purchase. Following the new law, the FDA has formally outlined rules for companies to follow when producing and selling their hearing aids over the counter. These regulations are intended to ensure consumer safety in purchasing OTC hearing aids. They also eliminate the requirement of consulting hearing professionals before purchase—a contributor to the high costs of prescription hearing aids. With some prescription hearing aids costing upward of $7,000, OTC hearing aids are anticipated to significantly lower the cost of hearing aids and make them more readily available to consumers. OTC hearing aids following FDA regulations hit the market in mid-October 2022.

Although they don’t require you take a test to confirm the severity of your hearing loss, OTC hearing aids are intended to treat mild to moderate hearing loss, not severe hearing loss. This means the perception of your hearing loss severity and whether OTC hearing aids are a good solution are up to your discretion. As a resource to help you decide if OTC hearing aids are right for you, many manufacturers offer free online hearing screenings and consults with their hearing professionals to determine if their models are appropriate for your hearing loss. Test results from online hearing screenings may be a good start in deciding if you should visit an audiologist for prescription hearing aids or shop online or in stores for OTC hearing aids

The OTC Hearing Aid Act, however, is not expected to have much impact on the cost of prescription hearing aids. Prescription hearing aids will continue to be available and are still necessary for more severe hearing loss. Current prescription hearing aids that treat milder hearing loss won’t be required to go over the counter. “Traditional hearing aids will still require a clinician to enter their audiogram, connect to the computer software in office, and adjust the devices to fit the prescriptive targets,” explained Amy Sarow, Au.D,

comparison of over the counter hearing aids

How Will Over-the-Counter Hearing Aids Be More Affordable?

Aside from eliminating the need for prescriptions from audiologists, OTC hearing aids will continue to be regulated by the FDA as medical devices with less strict regulations than prescription hearing aids. While prescription hearing aids are classified as medical devices in healthcare, the OTC hearing aid market’s fewer specific regulations for performance requirements and device design are expected to attract more tech companies to the production process. OTC hearing aids still, however, have to meet certain design and performance standards, such as having user-adjustable volume control and a limit on their insertion depth into the ear canal and maximum sound output. OTC hearing aid manufacturers are also required to simplify phrasing in their labeling and user manuals.

Sony, one of the world’s largest manufacturers of consumer tech products, has announced its partnership with the hearing aid manufacturer WS Audiology to sell OTC hearing aids. With fewer governmental hurdles, more companies that specialize in tech will likely invest in producing hearing aids, which should increase competition to offer hearing aids with better technology at lower prices.

Another reason OTC hearing aids will be more affordable is consumers won’t have to pay for the added services typically bundled into the device costs of prescription hearing aids. Often, when you purchase hearing aids, you’re paying for the devices and a package of services that include evaluation costs, follow-ups, and adjustment fees at a flat rate, regardless of how much or little you use those services. Additionally, prescription hearing aid manufacturers and retailers can limit access to the software used to adjust these hearing aids so that when you need your hearing aids adjusted, you’re limited to only the hearing clinics that have software access and to whatever price they decide to charge for their services. Fewer hearing clinics with access means less competition and potentially higher prices for services.

How much is the OTC Hearing Aid Act projected to lower the cost of hearing aids?

How Do Over-the-Counter Hearing Aids Differ From Direct-to-Consumer Hearing Aids Already on the Market?

OTC hearing aids will be the first to follow the FDA’s latest regulations, but in practice, they aren’t the first hearing aids sold outside of a hearing clinic without a prescription. Direct-to-consumer (DTC), FDA-registered brands, like Eargo, Jabra Enhance, and MDHearing, have been selling hearing aids online for the past several years. So, what’s the difference between OTC hearing aids and DTC hearing aids? OTC hearing aids will follow the FDA’s formalized guidelines.

“Prior to the OTC law…it was legal to sell hearing aids directly, either through the mail or online, without the need for a licensed pro, hence, DTC brands like ours,” said MDHearing’s CEO Doug Breaker. “It was NOT legal to sell in retail. The OTC law gets rid of DTC case law and replaces it with one national law. OTC allows direct sales and retail sales, both without the need for a licensed professional.”

In addition, Eargo’s CEO, Christian Gormsen, said, “Brands like Eargo…have sold direct to consumers without an exam or prescription for a few years. In both cases, the brands operated in a gray area and worked directly with the FDA to clear their claims. The new FDA ruling essentially takes unspoken rules that have developed over time and formalizes them into something that will allow for new players to innovate with clarity.”

While other hearing aid brands that you buy in stores such as Costco instead of at your traditional hearing clinic may appear to be OTC, Sarow explained that those hearing aids still require a hearing test and software to fit them according to your hearing prescription.

The majority of DTC hearing aid manufacturers will comply with FDA regulations for OTC hearing aids, allowing their devices to be sold directly to consumers in retail stores and online. The FDA lists which OTC hearing aid brands are FDA-registered.

Over-the-Counter Hearing Aids vs. Prescription Hearing Aids: Pros and Cons

The FDA authorizes OTC hearing aids to treat only mild to moderate hearing loss (as perceived by the person experiencing it) in adults 18 and older. Children with any degree of hearing loss and adults with moderate to severe hearing loss will still need prescription hearing aids. As a reference, the National Institutes of Health describes hearing loss that’s potentially too severe for OTC hearing aids as trouble hearing conversations in quiet settings or missing loud sounds when driving, like cars honking at you. 

Adults with mild to moderate hearing loss can purchase prescription instead of OTC hearing aids if they want custom-fit devices and services for adjustments from audiologists and hearing specialists. Adults who buy OTC hearing aids can still receive assistance from hearing professionals if they’d rather not adjust their hearing aids themselves or are having trouble using them.

Heather Malyuk, Au.D, head of audiology at Tuned, said one of the biggest pros of OTC hearing aids is that they bring “hearing care to the forefront of healthcare and general wellness” and give “access to affordable amplification.” She added, however, that a potential con comes into play “if consumers are not educated about the value an audiologist brings by helping assess or screen hearing, give recommendations, and help guide the consumer to the device that will best fit his or her needs and lifestyle.”

Although not required, some adults may wish to obtain a professional hearing evaluation before purchasing OTC hearing aids to confirm their type of hearing loss and get a professional’s recommendation, including which OTC brands they recommend.

In some cases, consulting with a hearing professional before purchasing hearing aids is important to rule out conditions other than age-related hearing loss. According to the American Speech-Language Hearing Association, consultation with a professional for prescription hearing aids may be more appropriate in the following situations:

  • Hearing loss in only one ear
  • Sudden hearing loss
  • Ringing, roaring, or beeping in one or both ears
  • Experiencing hearing loss after taking a medication associated with hearing loss
  • Having taken chemotherapy or receiving radiation to the head and neck region
  • Having constant ear pain
  • Having frequent dizziness

The American Academy of Audiology also recommends that people with complex medical needs, such as cognitive deficits or limitations using their hands, seek care from an audiologist. They caution that people experiencing changes to their hearing may want to seek medical attention before purchasing OTC hearing aids to avoid missing conditions that may not respond to hearing aids, like ear infections, earwax impaction, or, more rarely, tumors of the auditory nerve. 

Expectations of Consumers

By making OTC hearing aids easier to bring to market and more affordable, the hope is older adults with hearing loss will treat their hearing loss sooner. Early treatment of hearing loss in older adults is thought to decrease depression, anxiety, social isolation, and the likelihood of developing dementia.

However, although the price is a major barrier to buying hearing aids, it’s not the only barrier. People, including older adults, say there’s a stigma of being seen as old when wearing hearing aids. Some people in countries like Australia, Iceland, and Germany that offer free hearing aids paid for through public funds still refuse to wear hearing aids. Other hearing aid users complain they don’t like how hearing aids make things sound. Only time will tell how Americans will respond to OTC hearing aids, but at least hearing aids will be more accessible for those who want them.

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Dr. Kupfer is an Audiologist and Hearing Aid Specialist in NYC, where she works with adults and older adults daily. In addition to diagnosing hearing loss, tinnitus and fitting cutting-edge hearing aids in her private practice, she serves as adjunct clinical faculty for the CUNY Audiology Doctoral Program.

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Bass Alex. "Over-the-Counter Hearing Aids: Past, Present, Future" AgingInPlace.org. May 08, 2023. Web. Feb 21, 2024. <https://aginginplace.org/hearing-aids/over-the-counter-history/>.


Bass A. (2023, May 08). Over-the-Counter Hearing Aids: Past, Present, Future. AgingInPlace.org. https://aginginplace.org/hearing-aids/over-the-counter-history/


Alex Bass, "Over-the-Counter Hearing Aids: Past, Present, Future," last modified: May 08, 2023, https://aginginplace.org/hearing-aids/over-the-counter-history/.